Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH,
FDA device recall Z-0522-2013 · posted 2012-12-13 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
- Action taken
- Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272. For questions regarding this recall call 317-521-3966.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 23 units of Fluid Pack COOX, 200 were distributed
- Distribution
- Nationwide Distribution including NE and AZ.
- Date initiated
- 2012-11-14
- Date posted
- 2012-12-13
- Date terminated
- 2013-08-07
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) | Roche Diagnostics | 2012-05-14 |